(165 days)
No
The description details a standard process for designing and manufacturing clear aligners using existing dental software and manual review by a dental professional. There is no mention of AI or ML being used in the treatment planning or manufacturing process.
Yes
The device is indicated for the treatment of malocclusion, which is a medical condition, making it a therapeutic device. It positions teeth through continuous gentle force to treat this condition.
No
Explanation: The device description clearly states that a dental health care professional assesses the patient's teeth and determines a course of treatment. The Clear-Aligner system then produces trays based on this assessment and prescribed plan, which are used to gradually realign the patient's teeth. The system's purpose is to treat malocclusion, not to diagnose it.
No
The device description clearly states that the system involves the production of physical plastic trays (aligners) which are the primary therapeutic component. While software is used in the design process, the final device delivered to the patient is a physical product.
Based on the provided information, the Clear-Aligner system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Clear-Aligner's Function: The Clear-Aligner system is a physical device (plastic trays) used to mechanically move teeth. It does not involve the analysis of biological specimens from the patient.
- Intended Use: The intended use is for the "treatment of malocclusion," which is a physical condition, not a diagnosis based on laboratory analysis.
- Device Description: The description details the process of designing and manufacturing physical aligners based on molds of the patient's teeth and a treatment plan. It does not mention any laboratory testing or analysis of biological samples.
The Clear-Aligner system is a medical device used for treatment, specifically in the field of orthodontics. It falls under the category of devices used to physically alter the structure of the body (in this case, the position of teeth).
N/A
Intended Use / Indications for Use
The Clear-Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The Clear-Aligner system positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
A dental health care professional (e.q. orthodontist or dentist), using a standard personal computer prescribes the Clear-Aligner system based on an assessment of thee patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. Utilizing standard dental software used for tooth alignment, CDB then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, CDB produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (Dentition)
Indicated Patient Age Range
Patients with permanent dentition.
Intended User / Care Setting
Dental health care professional (e.q. orthodontist or dentist)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to ensure the accuracy of the final product carried through the entire process from the initial scan through treatment planning and manufacturing of the model to the final thermoformed aligner. Functional characteristics tested and the standard by which they were tested include the following, all pre-established specification and acceptance criteria:
- . Fit of the aligner against the treatment plan as determined by dental health professional
- Process consistency from the treatment plan file to 3D printed mold to final . aligner was measured against internal acceptance criteria derived by considering all sources of variation
The acceptance results observed during the verification and validation testing that has been conducted on these devices has shown that they are capable of performing to their stated intended use and specification requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2019
CDB Corporation Leah Lehman Quality & Regulatory Manager 9201 Industrial Blvd Leland, North Carolina 28451
Re: K191823
Trade/Device Name: Clear-Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 18, 2019 Received: November 19, 2019
Dear Leah Lehman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191823
Device Name Clear-Aligners
Indications for Use (Describe)
The Clear-Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The Clear-Aligner system positions teeth by way of continuous gentle force.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image shows the logo for CDB Ceramic Dental Brackets. The logo consists of a stylized blue triangle on the left and the text "CDB CERAMIC DENTAL BRACKETS" on the right. Below the logo is the text "510(k) Summary" in a large, bold font.
This 510(k) Summary is submitted in accordance with the requirements of 21CFR 807.92.
| Submitter: | CDB Corporation
9201 Industrial Blvd, NE
Leland, NC 28451 USA
Owner/Operator No.: 9002860
Establishment Registration No.: 1054415 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Leah M Lehman
Quality & Regulatory Manager
Phone: 910.383.6464
llehman@cdbcorp.net |
| Secondary Contact: | Jens Rumsfeld
Managing Director
Phone: 910.383.6464
jrumsfeld@cdbcorp.net |
| Date Prepared: | December 19, 2019 |
| 510k Submission: | K191823 |
| Device Name: | Clear-Aligners |
| Common Name: | Sequential Aligner |
| Classification Name: | Orthodontic Plastic Bracket |
| Regulation Number: | 21 CFR 872.5470 |
| Product Code: | NXC |
| Classification Panel: | Dental Products Panel 76 |
| Classification: | Medical Device, Class II |
Indications for Use:
The Clear-Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The Clear-Aligner system positions teeth by way of continuous gentle force.
4
Predicate Devices:
Clear Correct, Clear Correct Inc., K082556 (primary predicate) Invisalign, Align Technology, K981095 (reference device)
Device Description:
A dental health care professional (e.q. orthodontist or dentist), using a standard personal computer prescribes the Clear-Aligner system based on an assessment of thee patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. Utilizing standard dental software used for tooth alignment, CDB then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, CDB produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced in Table 1.
Technoloqical Characteristics:
Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves teeth to a desired end-state is the technological principle for both the subject and predicate devices. A comparison between technological characteristics of the Clear-Aligners and that of legally marketed predicate devices has been performed. The results of this comparison demonstrate that the design, technology, materials, and composition of the Clear-Aligners are substantially equivalent to the predicate devices.
5
Mechanism of Action:
The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
Performance Testing:
Bench testing was performed to ensure the accuracy of the final product carried through the entire process from the initial scan through treatment planning and manufacturing of the model to the final thermoformed aligner. Functional characteristics tested and the standard by which they were tested include the following, all pre-established specification and acceptance criteria:
- . Fit of the aligner against the treatment plan as determined by dental health professional
- Process consistency from the treatment plan file to 3D printed mold to final . aligner was measured against internal acceptance criteria derived by considering all sources of variation
The acceptance results observed during the verification and validation testing that has been conducted on these devices has shown that they are capable of performing to their stated intended use and specification requirements.
Further testing was not performed given there is sufficient information available from the scientific literature and from the predicate devices to demonstrate that sequential aligners provide reasonable assurance of substantial equivalence.
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Biocompatibility Testing:
The biological evaluation for the device was conducted in accordance with the US FDA Docket Number FDA-2013-D-0350, "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization
- Irritation ●
The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant. The results of the studies further support the determination of substantial equivalence.
Software Consideration
There are two areas in the Clear-Aligner process where software is used; they are the ordering process and treatment planning. The software usage in these areas is considered of moderate concern. Software testing has been performed to verify the function of the Clear-Aligners, which supports a substantial equivalence decision.
Substantial Equivalence Comparison:
The following table compares the Clear-Aligner system to the predicate devices, Clear Correct (primary predicate) and the Align System (reference device), with respect to intended use, technological characteristics, and principles of operation.
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| Feature | Clear-Aligners
Submission Device | Clear Correct
Primary Predicate | Align System
Reference Device |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K191823 | K082556 | K981095 |
| Manufacturer | CDB Corporation | Clear Correct Inc. | Align Technology |
| Regulation Number | 872.5470 | 872.5470 | 872.5470 |
| Device Classification | Aligner, Sequential | Aligner, Sequential | Aligner, Sequential |
| Product Code | NXC | NXC | NXC |
| Device Class | II | II | II |
| Indications for Use | The Clear-Aligner
system is indicated
for the treatment of
malocclusion in
patients with
permanent dentition.
The Clear-Aligner
system positions
teeth by way of
continuous gentle
force. | The Clear Correct
System is indicated
for the treatment of
tooth malocclusion in
patients with
permanent dentition
(i.e. all second
molars). The Clear
Correct System
positions teeth by
way of continuous
gentle force. | The Align System is
indicated for the
treatment of tooth
malocclusion in patients
with permanent dentition
(i.e. all second molars).
The Align System
positions teeth by way
of continuous gentle
force. |
| Mode of Action | Alignment of teeth by
sequential use of
preformed plastic
trays. | Alignment of teeth by
sequential use of
preformed plastic
trays. | Alignment of teeth by
sequential use of
preformed plastic trays. |
| Material | Thermoformed
Copolyester | Thermoformed
Polycarbonate | Thermoformed
Polycarbonate |
| Material Properties | Demonstrates
sufficient tensile
strength, elasticity,
ductility, chemical
resistance, and
clarity for use as a
clear tray aligner | Demonstrates
sufficient tensile
strength, elasticity,
ductility, chemical
resistance, and clarity
for use as a clear tray
aligner | Demonstrates sufficient
tensile strength,
elasticity, ductility,
chemical resistance,
and clarity for use as a
clear tray aligner |
| Software Used for
Ordering Workflow | Yes | Yes | Yes |
| OTC or Rx | Rx | Rx | Rx |
Table 1. Predicate Device Information Comparison
Substantial Equivalence Conclusion:
The conclusion drawn from the data included in this submission demonstrates that the Clear-Aligner system is substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mechanism of action, performance, materials, and biocompatibility.